Intratumoral INT230-6 Followed by Neoadjuvant Immuno-chemotherapy in Patients With Early TNBC. INVINCIBLE-4-SAKK

About 10-20% of all individuals with breast cancer have a so-called triple-negative tumor (TNBC). This type of breast cancer has a particularly unfavorable course and a higher mortality rate compared to other forms of breast cancer. Research studies show that it is important for individuals with TNBC to achieve a so-called pathologic complete response (pCR) to treatment. In the phase II study SAKK 66/22, it is being investigated whether the administration of the drug INT230-6 before surgery for breast cancer can increase the rate of pCR in the tumor and affected lymph nodes. The tolerability o

Trial Details

NCT ID
NCT06358573
Phase
PHASE2
Sponsor
Swiss Cancer Institute
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • INT230-6
  • neoadjuvant immuno-chemotherapy
Locations (sample)
  • Aarau, Switzerland|47.39254,8.04422
  • Basel, Switzerland|47.55839,7.57327
  • Bellinzona, Switzerland|46.19278,9.01703
  • Chur, Switzerland|46.84986,9.53287
  • Liestal, Switzerland|47.48455,7.73446

Key Eligibility Criteria

  • Written informed consent according to country specific law and ICH GCP E6(R2) regulations before registration and prior to any trial specific proce…
  • Newly histologically diagnosed, previously untreated locally advanced non-metastatic TNBC as defined by the most recent American Society of Clinica…
  • The following stages according to staging per American Joint Committee on Cancer (AJCC) for breast cancer staging criteria version 8 are included: …
  • Multifocal and multicentric primary tumors are allowed and the tumor with the most advanced T stage should be used to assess eligibility. If multif…

For full eligibility, visit ClinicalTrials.gov.

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